NCT04749160

Smart Marker Annunciating Response to Rheumatologic Treatments SMART²T

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 26 (actual)
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

European recommendations indicate to start a conventional synthetic disease modifying antirheumatic drug (csDMARD) as soon as possible to reach the remission in early RA or low disease activity in established RA. If the target is not achieved with the first csDMARD and in presence of poor prognostic, addition of a biologic (b)DMARD or a targeted synthetic (ts)DMARD should be considered . Nevertheless, as many as one-third of patients have persistent disease activity and insufficient (inadequate) response to a first b/tsDMARD according to international recommendations. This relatively long time (3 to 6 months) between treatment initiation and determination of individual clinical response represents: * a risk for the patient who could be usually exposed to potential side effects, * a loss of chance for the patient who will not receive an adequate treatment during the most favorable period and thus may develop irreversible lesions * a cost for the healthcare system, especially in terms of expensive drug reimbursements, notwithstanding the increasing use of biosimilars. Despite 20 years of research, no biomarker or no way are available in the daily practice to predict disease activity and the non-response to a b/tDMARD \[11\]. Thus exploration of a new approach is totally in purpose. The aim of this project is to benefit from the declarative PRO (Patient Reported Outcomes), the physical activity and sleep quality to predict the individual clinical response to the b/tsDMARDs

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DEVICE	Connected device	Connected device is a smart watch (with accelerometer without location data).

Timeline

• Start date: 2021-06-04
• Primary completion: 2022-02-20
• Completion: 2022-02-20
• First posted: 2021-02-11
• Last updated: 2024-01-18

Locations

13 sites across 1 country: France